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Description of key information

Naphthalenesulfonic acid, methyl, butyl, sodium salt (ANS B)(C7-alkyl naphthalene sulfonate) was found to be non-irritating to skin and irritating to the eyes in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 13 Nov 1978 and 16 Nov 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Pre GLP, performed according to US D.O.T standards
Qualifier:
according to guideline
Guideline:
other: US D.O.T. requirements
Version / remarks:
according to Section l73.240 (a) (1) Title 49 CFR and Section 1500.41 Title 16 CFR
Deviations:
no
Principles of method if other than guideline:
- Principle of test: For the D.O.T study. The methods employed in the testing, evaluation and scoring (according to Draize) of the results are similar to OECD 404. 0.5 g material is applied to the intact and abraded skin of 6 rabbits for 4 hours under closed conditions, with readings after end of exposure and at 24 and 48 hours..
For the irritation study however, exposure durtation is 24 hours, and readings are done after exposure (= 24 hours) and again at 72 hours after start of exposure.
- Parameters observed are Erythema and Eschar Formation, and Edema.
GLP compliance:
not specified
Remarks:
pre-GLP study
Specific details on test material used for the study:
Commercial product
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at two sites with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin on the other side was allowed to remain intact.
Type of coverage:
occlusive
Preparation of test site:
other: clipped, and either intact or abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
A 0.5 gm portion of the material was applied to two abraded and two intact skin sites on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material was wrapped snuggly around the trunks of the animals to hold the patches in place.
Duration of treatment / exposure:
4 hours (D.O.T. corrosion) and 24 hours (primary irritation)
Observation period:
Up to 48 hours (D.O.T. corrosion) and 72 hours (primary irritation)
Number of animals:
6
Details on study design:
The primary skin irritation study was conducted on the intact and abraded skin sites adjacent to each other towards the head end of the animal while the D.O.T. study was conducted on the intact and abraded skin sites adjacent to each other towards the tail end of the animal.
The wrappings were removed at the end of a four hour period for the D.O.T. study and the treated areas were examined. Readings were also made after twenty-four and forty-eight hours. The Draize method of scoring was employed.
The wrappings were removed at the end of a twenty-four hour period for the primary skin irritation study and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed.
Irritation parameter:
erythema score
Remarks:
4 hour exposure on intact (non-abraded) skin
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
0.33
Max. score:
1
Remarks on result:
probability of weak irritation
Remarks:
grade 1 eythema in 2/6 animals
Irritation parameter:
erythema score
Remarks:
4 hour exposure on intact (non-abraded) skin
Basis:
mean
Remarks:
of 6 animals
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 hour
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
4 hour exposure on intact (non-abraded) skin
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The 4 hour exposure did not result to formation of edema in any of the 6 animals at any of the time points. Erythema grade 1 was only visible after 24 hours on the skin of 2/6 animals following application on the intact skin. Application to the abraded skin only resulted to grade 1 erythema in 5/6 animals immediately after 4-hour application, but no erythema was observed at any of the other time points.
Interpretation of results:
GHS criteria not met
Conclusions:
Following application on the intact and abraded skin of 6 animals under occlusive conditions for 4 hours was practically non-rritating. Expsoures for 24 hours resulkted to mild irritation.
Executive summary:

Morwet B (Naphthalenesulfonic acid, methyl, butyl, sodium salt) was evaluated for dermal irritation and corrosion in a D.O.T. skin corrosion and a primary skin irritation study involving exposure to the intact and abraded skin of 6 albino rabbits.

Skin areas were clipped over a wide area. One side of the animals' backs was abraded at two sites with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin on the other side was allowed to remain intact.

A 0.5 gram portion of the material was applied to two abraded and two intact skin sites on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material was wrapped snuggly around the trunks of the animals to hold the patches in place.

 

The D.O.T. study was conducted on the intact and abraded skin sites adjacent to each other towards the tail end of the animal. The wrappings were removed at the end of a four hour period and the treated areas were examined. Readings were also made after twenty-four and forty-eight hours. The Draize method of scoring was employed.

 

The primary skin irritation study was conducted on the intact and abraded skin sites adjacent to each other towards the head end of the animal. The wrappings were removed at the end of a twenty-four hour period for the primary skin irritation study and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed.

 

Results:

The primary skin irritation study: Following 24 hour exposure to the intact skin under occlusive conditions resulted to only mild irritation. The erythema score was 1 or 2 in all animals at the 24 hour reading with a 1, 2 or 3 grade edema. At 72 hours only two animals still showed some signs of irritation with a grade 1 erythema and a grade 1 or 2 edema.

The results from 24 hour exposure to the abraded skin showed slightly higher reaction.

 

Average score Intact skin following 24 hour exposure:

- 24 h reading: erythema: 1.83; edema: 2.00

- 72 h reading: erythema: 0.33; edema: 0.50

Average score Intact skin following 24 hour exposure:

- 24 h reading: erythema: 1.83; edema: 2.17

- 72 h reading: erythema: 1.00; edema: 1.17

 

D.O.T. study for skin corrosion: The 4 hour exposure did not result to formation of edema in any of the 6 animals at any of the time points. Erythema grade 1 was only visible after 24 hours on the skin of 2/6 animals following application on the intact skin. Application to the abraded skin only resulted to grade 1 erythema in 5/6 animals immediately after 4-hour application, but no erythema was observed at any of the other time points.

 

Average score Intact skin following 4 hour exposure:

- 4 h reading: erythema: 0; edema: 0

- 24 h reading: erythema: 0.33; edema: 0

- 48 h reading: erythema: 0; edema: 0

Average score Intact skin following 4 hour exposure:

- 4 h reading: erythema: 0.83; edema: 0

- 24 h reading: erythema: 0; edema: 0

- 48 h reading: erythema: 0; edema: 0

 

The results from the 4-hour exposure can be used for GHS classification, and indicate that Morwet B does not need to be classified for skin erritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study period: Between 20 Nov 1978 and 27 Nov 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
The methods employed in the testing, evaluation and in the grading of the test material are those described in Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, P. 27019, 27 September 1973.
Deviations:
no
Principles of method if other than guideline:
0.1 mg of unwetted material was instilled in the right eyse of 6 albino rabbits. The material was not washed from the eyes. Observations were made up[ to 7 days after installation.
Evaluations were done according to Draize, involving the same elements as OECD 405 grading.
GLP compliance:
not specified
Remarks:
Study from before GLP
Specific details on test material used for the study:
Commercial product.
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Six healthy young adult albino rabbits.
No futher infomation
Amount / concentration applied:
Test material was used as supplied. 0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls.
Duration of treatment / exposure:
The test material was not washed from the eyes.
Observation period (in vivo):
Up to 7 days.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Draize scoring system was applied
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.78
Max. score:
2
Reversibility:
other:
Remarks:
Expected full reverisble within 21 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1.44
Max. score:
2
Reversibility:
other:
Remarks:
Expected full reverisble within 21 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.94
Max. score:
3
Reversibility:
other:
Remarks:
Expected full reverisble within 21 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
other:
Remarks:
Expected full reverisble within 21 days.
Remarks on result:
positive indication of irritation

Scoring:

    cornea Iris Conjunctivae
Time rabbit opacity area   redness Chemosis Discharge
1 hour 1 1 4 1 3 3 3
2 2 4 2 3 3 3
3 1 4 1 3 3 3
4 1 4 1 3 3 3
5 2 4 2 3 3 3
6 1 4 1 3 3 3
24 hrs 1 2 4 1 2 3 3
2 3 4 2 2 4 3
3 2 4 2 3 4 3
4 2 4 2 2 3 3
5 2 4 2 3 3 3
6 2 4 2 3 4 3
48 hrs 1 1 4 1 2 2 2
2 2 4 2 2 2 2
3 2 4 1 2 2 2
4 2 4 1 2 2 2
5 2 4 1 2 2 2
6 2 4 2 2 2 2
72 hrs 1 1 4 1 1 2 1
2 2 4 1 2 2 2
3 1 4 1 1 1 1
4 1 4 1 1 1 2
5 1 4 1 1 1 2
6 2 4 2 2 2 2
5 days 1 0 0 0 1 1 1
2 1 4 1 1 1 2
3 0 0 0 1 1 1
4 0 0 0 1 1 1
5 0 0 0 1 1 1
6 1 4 0 1 1 2
7 days 1 0 0 0 1 1 1
2 0 0 0 0 1 1
3 0 0 0 0 1 0
4 0 0 0 1 0 0
5 0 0 0 1 1 1
6 0 0 0 0 1 0
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
0.1 mg in the eyes of 6 rabbits resulted to clear signs of irritation in all rabbits, which was maximal at 24 hours and gradually declined afterwards.
Executive summary:

Morwet B (Naphthalenesulfonic acid, methyl, butyl, sodium salt) was evaluated for eye irritation in the rabbit. Six healthy young adult albino rabbits were used in this study. 0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes.

The treated eyes were examined at 1, 24, 48 8 72 hours and 5 and 7 days following instillation of the test material into the eyes. Interpretation of the results was made in accordance to Draize, involving Cornea opacity (1-4) and area (1-4), iris (1-2) and Conjunctiva redness (1-3), chemosis (1-4) and discharge (1-3).

 

Below the average scores from the 6 animals over the observation period of 7 days.

Time

Cornea

Iris

Conjunctiva

redness

Chemosis

Discharge

1

1.3

1.3

3.0

3.0

3.0

24

2.2

1.8

2.5

3.5

3.0

48

1.8

1.3

2.0

2.0

2.0

72

1.3

1.2

1.3

1.5

1.7

120

0.3

0.2

1.0

1.0

1.3

168

0.0

0.0

0.5

0.8

0.5

 

Although most animals still show some effects on conjunctivae on day 7 (grade one on redness and/or chemosis and/or discharge), it can be expected that when the observation period was extended to 21 days, these will completely disappear. (See attached graph with observed average scores up to 168 hours / 7 days)

 

For evaluation for GHS classification, the averages for 24, 48 and 72 hours are calculated per animal:

rabbit

opacity

iris

redness

1

1.3

1.0

1.7

2

2.3

1.7

2.0

3

1.7

1.3

2.0

4

1.7

1.3

1.7

5

1.7

1.3

2.0

6

2.0

2.0

2.3

  Calculating the averages for 24, 48 and 72 hours per animal, show that GHS criteria for Cat.2 are met with scores for corneal opacity1 and iris score1 for all animals, and conjunctival redness2 for 4/6 animals.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

Naphthalenesulfonic acid, methyl, butyl, sodium salt (ANS B) (C7-alkyl naphthalene sulfonate) was evaluated for dermal irritation and corrosion in a D.O.T. skin corrosion and a primary skin irritation study involving exposure to the intact and abraded skin of 6 albino rabbits.

The primary skin irritation study, following 24 hour exposure to the intact skin under occlusive conditions, resulted to only mild irritation. The erythema score was 1 or 2 in all animals at the 24 hour reading with a 1, 2 or 3 grade edema. At 72 hours only two animals still showed some signs of irritation with a grade 1 erythema and a grade 1 or 2 edema. The results from 24 hour exposure to the abraded skin showed slightly higher reaction.

D.O.T. study for skin corrosion, following 4 hour exposure, did not result to formation of edema in any of the 6 animals at any of the time points. Erythema grade 1 was only visible after 24 hours on the skin of only 2/6 animals following application on the intact skin. Application to the abraded skin only resulted to grade 1 erythema in 5/6 animals immediately after 4-hour application, but no erythema was observed at any of the other time points.

 

Eye irritation:

ANS B was also evaluated for eye irritation in the rabbit. Six healthy young adult albino rabbits were used in this study. 0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1, 24, 48 8 72 hours and 5 and 7 days following instillation of the test material into the eyes. Interpretation of the results was made in accordance to Draize, involving Cornea opacity (1-4) and area (1-4), iris (1-2) and Conjunctiva redness (1-3), chemosis (1-4) and discharge (1-3).

Although most animals still showed some effects on conjunctivae on day 7 (grade one on redness and/or chemosis and/or discharge), it can be expected that when the observation period was extended to 21 days, these effects would have been completely disappeared.

Calculating the averages for 24, 48 and 72 hours per animal, shows a corneal opacity1 and an iris score1 for all animals, and conjunctival redness2 for 4/6 animals.

Justification for classification or non-classification

Based on persisting erythema in two of the three animals at the end of the observation period in thein vivoskin irritation study in rabbits,Bis(1-methylethyl)-, methyl naphthalene sulfonate, sodium saltshould be classified for CLP as: skin irritant (Category 2) withH315: Causes skin irritation.

The results from thein vitroeye irritation study (BCOP) showed an IVIS score of73.62.IVIS above > 55 result to classification for CLP with Category 1,H318: Causes serious eye damage.

 

The results from the 4-hour skin exposure can be used for GHS classification, and indicate that ANS B does not need to be classified for skin irritation.

The average scores for 24, 48 and 72 hours per animal in the eye irritation study show that GHS criteria for Cat.2 are met with scores for corneal opacity1 and iris score1 for all animals, and conjunctival redness2 for 4/6 animals.

 

There is no information on possible respiratory irritation, so no conclusion can be made regarding STOT SE cat.3 classification for Respiratory tract irritation.

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